Needle for medical use with safety protection

ABSTRACT

A needle is provided with a protective cap which is substantially cylindrical in shape and has one open end and an opposed tapered end having a central hole through which the needle can emerge. The cap has a diameter so that in use it can slide onto a cylindrical body which carries the needle.

The present invention refers to a needle for syringes, for drawingsamples with a vacuum test-tube for endovasal and similar uses, having asafety protection, suitable for eliminating any danger of wounding afteruse.

As is already known, the throw-away needles which exist on the marketare usually applied to the corresponding syringes and are covered by aprotective cap, which is slid oaf at the moment they are used.

The cap, which is substantially cylindrical or slightly conical inshape, with an opening at the wider end, must be replaced in position onthe needle after the injection has been made, and this is necessaryobviously to avoid leaving the needle uncovered, which could wound, forinstance, the refuse collection staff.

Since the opening of the protective cap of the needle is relativelysmall, there exists a risk of the needle not centring it when it isbeing reinserted into the cap, and consequently wounding the user. Thiscan happen at any time, simply through carelessness but more probablythrough the tiredness of the medical or paramedical staff at the end ofa hospital duty shift.

The danger of the user being wounded is a major problem today,considering the existence of diseases, some of them fatal, such as theacquired immunity deficiency syndrome (AIDS), which are transmittedthrough being pricked by infected needles.

In order to eliminate or at least avoid any danger of wounding whencovering the needle after the syringe has been used, it has already beensuggested to foresee a protective cap of the needle, which can beadjusted from a rest position, in which it completely covers the needle,to a use position, in which it places itself around the syringe, thusexposing the needle. After the injection has been made the cap can beslid onto the needle again.

Such a method is known for example from U.S. Pat. No. A-4,968,304,wherein the needle and the related cap are usually separated by thesyringe, the connection of the needle with the syringe taking place bymeans of a screw mounting. A closing plug is provided on the cap, whichmust be removed before use and replaced after use. During suchoperations there always exists the risk of the user to be wounded.

A similar method is disclosed in U.S. Pat. No. A-4,961,730 whichforesees elastic means, in correspondence with the base of the needle,co-operating with the inner surface of the cap, suitably shaped, toobtain the locking of the needle inside the cap.

This solution which is quite complicated, expensive and difficultlyfeasible, does not allow a completely safe locking of the needle due tothe presence of said elastic means.

Both methods disclosed in U.S. Pat. No. A-4,968,304 and U.S. Pat. No.A-4,961,730 are specifically conceived for hypodermic syringe needles sothat their application to needles for different uses, such ascannula-needles or butterfly needles for endovasal use, is hardlyenvisageable.

FR-A-2 620 942 describes a syringe for dental use, wherein a protectivecap is provided on the needle, which is brought over the syringe bodyduring the use. Also in this case it cannot be envisaged an applicationof the protective cap For other kinds of needle.

The aim of the invention is to eliminate the drawbacks set forth aboveand revolutionize the solution proposed in the aforementioned priorarts, providing an extremely simple, cheap and safe method to protectthe needle, which applies to whatsoever kind thereof.

The aim is achieved, according to the invention, by means of thefeatures listed in the characterizing portion of the attached claim 1.

Advantageous embodiments of the invention are disclosed in the dependentclaims.

In particular, according to a modified embodiment, the needle can beused for drawing samples with vacuum test-tubes in place of syringes.

According to the known art, For this type of application two opposedneedles with respective protective caps are foreseen. One of suchneedles is intended to be inserted into the vein while the other is forinserting into a vacuum test-tube, in which the blood is collected. Atthe base of the latter needle a threaded tang is foreseen, onto which atubular element is screwed at the moment of use. In this application,the same problems arise as those described for syringes.

According to this embodiment of the invention, a cylindrical sleeve isforeseen at the opposite part of the needle point, which is enbloc withthe base and encloses a second needle which Forms an extension of thefirst, the protective cap being moved on said sleeve during use. Afteruse, the cap is replaced on the first needle, as in the case of theneedle for syringes, while the second needle still remains protected bythe coupling.

In a second modified embodiment the needle is a cannula-needle endovasaluse, e.g. to administer fluids or for similar uses.

A cannula-needle is made of a metallic guide needle or "mandrel"enclosed in a flexible plastic material cannula. During use the whole isinserted in the vein as a common needle, then the metallic guide needleis extracted, for example to connect the cannula with a phleboclysis tobe dripped to the patient. During such an operation there exists therisk of the user to be wounded.

According to this modified embodiment of the invention the protectivecap is placed between the guide needle and the cannula, more preciselybetween a cylindrical handle of the guide needle and a tubular supportof the cannula, the guide needle being housed in said cap while it isbeing extracted, and is locked in it after rotation, as in the precedingcases. The guide needle and the cap can be thus removed enbloc from thecannula and thrown in a refuse collector for the further disposalwithout risk of wounding.

In a third modified embodiment the needle is a butterfly needle, alwaysfor endovasal use.

As known, a butterfly needle has, in correspondence with the base, twoopposite flexible wings, intended to facilitate its introduction in thevein and the subsequent locking, and carries a rear connecting littletube.

According to this modified embodiment of the invention, the two wingsare fixed to the base or needle body only for a short part, so as toallow the insertion between them of the protective cap which is placedon the needle, after use, and locked by means of rotation. In thisapplication two opposite coupled blades forming respective guides forthe sliding of the butterfly needle wings ere suitably provided on thecap in substitution for the longitudinal guides usually foreseen on thecap.

Further characteristics of the invention will be more clearly understoodfrom the detailed description given below, which refers to its purelyexemplary and therefore not restrictive embodiments, illustrated in theappended drawings, in which:

FIG. 1 is a side elevation of a needle for syringes according to theinvention;

FIG. 2 is a view of the needle in FIG. 1, rotated through 90°;

FIG. 3 is a top plan view of the needle;

FIG. 4 is a top plan view of the protective cap of the needle;

FIGS. 5 and 6 are median sections of the cap taken according to linesV--V and VI--VI respectively in FIG. 4;

FIGS. 7 and 8 are transverse sections of the cap taken along linesVII--VII and VIII--VIII respectively in FIG. 5;

FIG. 9 is a median sectional view of the cap, complete with needle,applied to a syringe, before the cap is slid off;

FIGS. 10 and 11 are transverse sectional views taken along line A--A inFIG. 9, with the cap shown in two positions, rotated through 90° withrespect to each other;

FIG. 12 is a view like the one in FIG. 9, with the cap carried on thetubular support of the needle, which is ready for use;

FIG. 13 shows, partially in view and partially in median section, afirst modified embodiment of the needle with the safety protectionaccording to the invention, usable for taking samples with a vacuumtest-tube;

FIG. 14 is an exploded schematic view of a second modified embodiment ofthe invention concerning a cannula-needle;

FIG. 15 is a view of the cannula-needle in FIG. 14 in an assembledposition.

FIG. 16 is a view of the guide needle extracted from the cannula andprotected by the cap.

FIG. 17 is an enlarged section of the cap end, indicated by A in FIG.14, substantially corresponding to the section of FIG. 5;

FIG. 18 is a section, taken along line XVIII--XVIII of FIG. 17, equal tothe section of FIG. 7;

FIG. 19 is a section, taken along line XIX--XIX of FIG. 17, equal to thesection of FIG. 8;

FIG. 20 is a view along line XX--XX of FIG. 14 equal to the view of FIG.3;

FIG. 21 is an exploded view of a third modified embodiment relevant tothe butterfly needle;

FIG. 22 is a view of the butterfly needle in FIG. 21 ready for use.

FIG. 23 is a view of the butterfly needle after being used with the capcovering the needle;

FIGS. 24 and 25 are top views of the sole cap and of the sole butterflyneedle respectively;

FIGS. 26 and 27 are sectional views taken along lines XXVI--XXVI andXXVII--XXVII in FIG. 21;

FIG. 28 is a section taken along line XXVIII--XXVIII in FIG. 27.

With reference to such figures, and starting with the figures from 1 to12, reference numbers 1 and 2 show respectively the needle and therelated protective cap according to the invention.

The needle 1 is a perfect ordinary needle for a syringe, having a point3 and a base 4 at the opposite end, from which a tubular support 7projects, with a central hole 5 intended for housing the tang 6 of thesyringe 7bis (see in particular FIGS. 9 and 12). The differences withrespect to a traditional needle are represented by the shape of the base4, which is widened and substantially oval, with two opposed notches 8,the purpose of which will be described below, and by the tubular support7 at the back of the base 4.

The cap 2 has a substantially cylindrical form, with an internaldiameter which enables it to slide onto the tubular support 7 (FIG. 12),and it has an open end 9 and the other end tapered with a centralopening 10 for the needle 1 to emerge. A flange 11 can be foreseen incorrespondence with the opening 9, to make it easier to hold.

Near the opening 9, inside the cap 2, a continuous or broken annularprojection 12 is foreseen, which forms a ledge suitable for preventingthe needle emerging from the opening 9.

Below the stop collar 12 two opposed half-moon projections 13 areforeseen, in such a way that a seating 14 is defined between the collar12 and the projections 13, intended for housing the base 4 of the needle1.

Inside the cap 2 two opposed longitudinal guides 15 are also foreseen,capable of engaging with the notches 8 foreseen on the base 4 of theneedle 1, to guide the sliding of the cap 2.

In the seating 14 for the base 4 of the needle, two teeth 16 can beforeseen, acting as stops for the rotation of the cap 2 with respect tothe needle I or viceversa.

The needle 1 is inserted into the protective cap 2 during the productionphase, by making it pass over the annular projection 12 at the base 4 bymeans of heating and/or pressure.

The needle and the related protective cap are then packed in a sealedbag and sold separately or already applied to the syringe 7, as shown inFIG. 9, and packed together with the latter.

During use, if the needle 1 has not been applied to the syringe 7bisyet, the tang 6 of the syringe is inserted into the hole 5 of thetubular support 7 of the base 4 of the needle, as shown in FIG. 9.

In such a position, the base 4 of the needle 1 is positioned so that itis locked between the upper annular projection 12 and the lowerprojections 13. Then the cap 2 is rotated, through an angle of about90°, for example, so as to bring the opposed guides 15 in line with thenotches 8 of the base 4 of the needle (FIG. 11). Centring the notches 8can be facilitated by correctly locating the teeth 16 foreseen in theseating 14. The cap 2 can then be slid off upwards, in the oppositedirection from the point 3 of the needle 1, and position itself aroundthe tubular support 7, remaining integral with the latter temporarilythrough the slight interference which exists between at least one of theprojections 12 and 13 and the outer surface of the tubular body itself,as shown in FIG. 12.

After the injection has been made--an operation which is not in theleast impeded by the cap 2--the cap 2 is once more slid downwards inorder to cover the needle 1, until the base 4 of the needle positionsitself in the seating 14, after which the cap 2 is rotated in theopposite direction from the previous one, so as to bring the base 4 toengage with the half-moon projections 13, and therefore prevent thepossibility of the needle sliding out of its own accord.

At this point, since the syringe 7bis is usually of the throw-away type,it is thrown into the appropriate containers together with the needleand the related protection.

If, however, for any reason, it is desired to remove the needle from thesyringe, this can be done easily by exercising traction on the cap 2 androtating it further so that the engagement of the teeth 16 with the base4 of the needle 1 produces a rotation of the latter, and therefore makesit easier to disconnect the tang 6 of the syringe, as, in fact, takesplace in the case of needles of the traditional type.

From what has been described, it is easy to see the advantages of theneedle with its related protective cap according to the invention, whichcan be applied to a syringe of any size, without varying the size of thecap 2 and, consequently, the size of the base 4 of the needle 1.

As an alternative to what has been shown in FIGS. 1 to 12, the needle 1can be made without the rear tubular support 7 and the cap have a largerdiameter so as to be carried directly on the syringe 7bis.

A description is now given of the modified embodiments of the inventionkeeping the same references used in the previous figures to indicate thesame parts, and adding a prime to the references which indicate partswhich are similar.

FIG. 13 shows a needle for drawing samples with vacuum test-tubes.

As can be seen in such figure, the only difference with respect to theneedle for syringes illustrated in FIGS. 1 to 12 consists, insubstitution for the tubular support 7, in the presence of a secondneedle 1' with a point 3', on axis and in opposition to the mainneedle 1. The needle 1', which is usually shorter than the needle 1,projects from the centre of the base 4, which in this case obviouslydoes not have the central hole 5.

Likewise, from the base 4, in the same direction as the second needle1', a cylindrical sleeve 7' projects, which encloses the needle 1', andon which the cap 2 is positioned during use.

In fact, during use, the needle 1 is inserted into the vein, and theneedle 1' is inserted into a vacuum test-tube, which is housed in thecylindrical sleeve 7', for collecting the blood.

The needle protection system in FIG. 13 is therefore exactly the same asthat of the needle illustrated in the figures from 1 to 12.

The modified embodiment shown in FIGS. 14 to 20 relates to acannula-needle which, as known, comprises a guide needle or mandrelprovided with a rear cylindrical handle 7" and a cannula 20 surroundingthe needle 1 and having at its back a tubular body 21 partially housingthe handle 7" of the needle.

Two opposed wings 22 intended for example to lock the cannula on thepatient's skin by means of plasters are foreseen on the body 21.

According to the invention the handle 7" of the needle is suitablylengthened and the protecting cap 2, completely similar in its structureto the cap of FIGS. 4-8, is placed between it and the tubular body 21 ofthe cannula.

The cannula-needle is packed in the assembled condition of FIG. 15, orpossibly with the metallic guide needle or mandrel 1 slightly retracted,in such a way that its point 3 does not project beyond the end of thecannula 20.

During use the needle 1 is inserted in a vein or in an artery causingthe contemporary insertion of the cannula 20. Then the needle 1 isretracted acting on its cylindrical handle 7", keeping the cap in theposition of FIG. 15, i.e. housed in the tubular body 21 of the cannula20. A coupling with a slight interference between the cap 2 and thetubular body 21 can be also foreseen. When the needle is completelyretracted so as to be entirely housed in the cap 2, that is when itsbase or collar 4 positions itself in the seating 14 of the cap, arotation through about 90° is carried out to lock it in that position.The guide needle 1 and the cap 2 can be thus slid off from the cannula,as shown in FIG. 16, and thrown in a refuse collector for the furtherdisposal thereof without risk of wounding.

A connector, for example to drip a phleboctysis to a patient, can bethen connected to the end of the tubular body 21. A further connectorcould be possibly foreseen at a side of the body 21.

A description is now given of the modified embodiment shown in FIGS. 21to 28, relevant to a butterfly needle for endovasal use comprising aneedle 1 with a tubular body 7"' in correspondence of which two opposedflexible wings 30 are foreseen to facilitate the introduction of theneedle into the vein and the subsequent locking of the same by means ofplasters.

A little tube is connected to the back of the body 7"', in a known way,to drip for example a phleboclysis to the patient.

The flexibility of the wings 30 is obtained by means of weakening ribs31 (see in particular FIG. 25).

According to the invention the wings 30 are fixed to the body 7"' onlyby a short rear part 32 so as to form long slits 33 for the insertionbetween them of the protective cap 2.

When packed, the cap 2 can be placed in the position shown by dottedlines in FIG. 22 and brought, during use, in the position shown byunbroken lines in the same figure.

In alternative, the cap 2 can be placed during packaging in the positionshown by unbroken lines in FIG. 22, any auxiliary little plastic tubebeing foreseen to protect the needle 1.

After it has been used the cap 2 is slid off onto the needle 1 until itsbase or collar 1 is inserted in the housing 14 foreseen inside the cap2. The cap is then rotated through about 90° and locked in such aposition (FIG. 23).

According to this embodiment pairs of opposed wings 34, 35, preferablydifferent in length, are foreseen outside the cap 2 to determinecorresponding seatings 36 to house the wings 30 of the butterfly needle.In this way the longitudinal sliding guides 15, which are foreseen inthe cap 2 according to the preceding embodiments, can be eliminated.

We claim:
 1. A needle for medical use, provided with a protective cap(2) substantially cylindrical in shape, with one open end (9) and anopposite opening (10), the diameter of the cap (2) being such that itcan slide on a cylindrical body provided at the back of the needle tomove from a needle covering position to a position in which the needleis uncovered and vice versa, wherein said cylindrical body (7, 7', 7",7"') is integral with the needle (1) and inside the cap (2), near theopen end (9) a seating (14) is provided, suitable for receiving asubstantially oval widened base or collar (4) of the needle (1), theseating (14) being limited at the top by a continuous or broken annularprojection (12) forming an insurmontable ledge for the base of theneedle, and at the bottom by two opposed "half-moon" projections (13),shaped in such a way as to allow the base ( 4 ) of the needle (1) topass, after correct positioning.
 2. A needle according to claim 1,wherein inside the said seating (14) at least one tooth (6) is provided,acting as a stop for the rotation of the cap (2) with respect to thebase (4) or vice versa.
 3. A needle according to claim 1, wherein on thebase (4) of the needle (1) at least one notch (8) is provided, suitablefor engaging with a corresponding longitudinal guide (15) providedinside the cap (2) for a guided sliding between the needle and the cap.4. A needle according to claim 1 wherein at least the projection (12) orthe projections (13), or both, have dimensions such that they interfereslightly with the outer surface of the cylindrical body (7, 7', 7",7"'), so as to make the cap (2) integral with the cylindrical duringuse.
 5. A needle according to claim 1 wherein the said opening (10) ismade centrally at a tapered end of the cap (2).
 6. A needle according toclaim 1 wherein said cylindrical body is a tubular support (7) at theback of the base (4) and integral with the needle (1) for connection toa tang (6) of a syringe (7bis) (FIGS. 1-12).
 7. A needle according toclaim 1 wherein said cylindrical body is a sleeve (7') integral with theneedle (1) and encloses a second needle (1') disposed axially with theneedle (1) (FIG. 13).
 8. A needle according to claim 1 wherein saidneedle (1) is the guide needle or mandrel of a cannula needle, andwherein said cylindrical body is a handle (7") of the guide needle (1)and the cap (2) is located between said handle (7") and a tubular body(21) of the cannula (20) (FIGS. 14-20).
 9. A cannula-needle according toclaim 8, wherein two flexible wings (22) are provided outside saidtubular body (21).
 10. A needle according to claim 1 wherein saidcylindrical body is the body (7"') of a butterfly needle, provided withtwo flexible opposed wings (30), said wings (30) being fixed to the body(7"') of the needle (1) only by a short rear part (32), so as to definelongitudinal slits (33) for the insertion between them of the protectivecap (2) (FIGS. 21-28).
 11. A butterfly needle according to claim 10,wherein pairs of opposed wings (34, 35) forming seats (36) are providedon said cap (2) to house and make the wings (30) of the butterfly needle(1) slide.
 12. A butterfly needle according to claim 11, wherein saidwings (34, 35) are different in length.
 13. A needle according to claim1 which is packed in a sealed bag together with the related protectivecap (2).
 14. A syringe for injections, which is provided with a needle(1) with a related protective cap (2), according to claim
 1. 15. Aneedle according to claim 3, wherein the base of the needle is providedwith at least two opposed notches.